MEDRAD® Avanta Multi-Patient Disposable Hand Controller AVA 500 HC

GUDID 40616258021650

ASSY,HAND CONTROLLER,AVANTA,MC,WLD (86574160)

BAYER MEDICAL CARE INC.

Contrast medium injection system hand controller kit

• Primary Device ID: 40616258021650
• NIH Device Record Key: f131b245-2584-431f-8806-3568450ee449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Multi-Patient Disposable Hand Controller
• Version Model Number: AVA 500 HC
• Catalog Number: AVA 500 HC
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021652 [Primary]
GS1	40616258021650 [Package]; Contains: 00616258021652; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050456

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Avanta Multi-Patient Disposable Hand Controller]

• 40616258010852: Avanta Hand-Controller (CONTROLLER, HAND - STERILE, RU, MC) (85633554)
• 40616258010173: Avanta Hand-Controller (CONTROLLER, HAND - STERILE, MC,JA2) (85231480)
• 10616258007868: Avanta Hand-Controller (CONTROLLER, HAND - STERILE, MC,CH) (60729547)
• 10616258005567: Avanta Hand-Controller (MEDRAD AVANTA HAND CONTROLLER) (60729520)
• 10616258005338: Avanta Hand-Controller (ASSY, FINISHED, HAND CONTROLLER, AVANTA) (60729555)
• 40616258021650: ASSY,HAND CONTROLLER,AVANTA,MC,WLD (86574160)